POS1532-HPR SEX DIFFERENCES IN THE EXPERIENCED BURDEN OF ADVERSE DRUG REACTIONS ATTRIBUTED TO ADALIMUMAB AND ETANERCEPT BY PATIENTS WITH IMMUNE-MEDIATED INFLAMMATORY DISEASES
Authors: H. Gosselt, J. Van Lint, L. Kosse, S. Tas, P. Spuls, H. Vonkeman, M. Nurmohamed, M. Van Doorn, B. Van den Bemt, N. Jessurun
Journal: Annals of the Rheumatic Diseases (2022)

Background Patients experience burden of adverse drug reactions. 1 So far, it is not known whether men and women experience adverse drug reactions (ADRs) with the same burden. Objectives To examine sex differences in regard to the burden of mutually reported ADRs in patients with immune-mediated inflammatory diseases (IMIDs) treated with adalimumab or etanercept. Methods Patients with rheumatoid arthritis (RA), psoriatic arthritis or (axial) spondyloarthritis using etanercept or adalimumab were included from the Dutch Biologic Monitor (DBM). 1 In the DBM, questionnaires concerning experienced ADRs and corresponding burden were filled out bimonthly. ADRs were coded according to Medical Dictionary for Regulatory Activities (MedDRA) terminology. The burden of ADRs (Preferred term level, PT) was reported on a five-point Likert scale ranging from no burden (1) to very high burden (5). If ADRs were present over multiple questionnaires, burden was only assessed the first time the ADR was mentioned. Likert scales reported for burden were compared between male and female patients for mutually reported ADRs that were reported at least four times by both male and female patients, using the Cochran-Armitage test for trend, which considers the ordinal nature of Likert scales. Results In total 748 consecutive patients participated, of which 55% were female (Table 1). Almost half (48%) reported at least one ADR during the study. More than half of female patients (55%) reported at least one ADR as compared to 38% of male patients. In total 882 ADRs were reported comprising 264 distinct ADRs, of which the majority (74%) was reported by female patients. 71 (27%) distinct ADRs were mutually reported by male and female patients and 12 (5%) distinct ADRs were reported at least four times by females and males. Pneumonia and headache impose the highest burden of the mutually reported adverse drug reactions. ‘Arthralgia’ (p=0.052) showed the largest differences burden Likert scale scores between male and female patients. Even though male patients experienced higher burden, these differences were not statistically significant (Figure 1). Conclusion Although women reported the majority of the ADRs, there was a trend that that men experienced certain ADRs as more burdensome in comparison to women, albeit this did not reach statistical significance. References [1]van Lint JA, Jessurun NT, Hebing RCF, et al. Patient-Reported Burden of Adverse Drug Reactions Attributed to Biologics Used for Immune-Mediated Inflammatory Diseases. Drug Saf 2020;43:917-25. Table 1. Demographics of females and males that reported at least one of the 12 distinct adverse drug reactions (ADRs) that are included in the analysis of sex-specific burden of ADRs. Participants Female Male N 138 70 Age, mean ± SD a 53.7 ± 13.5 57.6 ± 11.8 Indication for bDMARD therapy b , N (%) Ankylosing spondylitis/axial spondyloarthritis 15 (10.9) 14 (20.0) Ankylosing spondylitis/axial spondyloarthritis and Psoriatic arthritis 1 (0.7) - Ankylosing spondylitis/axial spondyloarthritis and Rheumatoid arthritis 1 (0.7) 3 (4.3) Psoriatic arthritis 26 (18.8) 25 (35.7) Rheumatoid arthritis 95 (68.8) 28 (40.0) bDMARDs, N (%) Adalimumab 60 (43.5) 32 (45.7) Etanercept 77 (55.8) 38 (54.3) Switched adalimumab/etanercept 1 (0.7) - Comedication, N (%) c Methotrexate 55 (39.1) 21 (30.0) Corticosteroids 17 (12.3) 11 (15.7) Thiopurines 3 (2.2) 1 (1.4) Sulfasalazine 9 (6.5) 3 (4.3) a Age was missing for 1 male and 1 female patient. b Patients could report multiple indications. 5 male and 14 female participants also reported other indications. c Reported comedication at the moment of inclusion. Eleven patients (male=3, female=8) did not start with etanercept or adalimumab at the moment they were included. In these cases, comedication is counted from the moment they reported the start of adalimumab or etanercept treatment. Figure 1. Sex-specific burden of mutually reported adverse drug reactions. Disclosure of Interests Helen Gosselt: None declared, Jette van Lint: None declared, Leanne Kosse: None declared, Sander Tas Consultant of: Gebro, GSK, AbbVie, Galvani, Arthrogen/MeiraGTx, Galapagos, Grant/research support from: Pfizer, GSK, Celgene, BMS, Sanofi, AstraZeneca, Phyllis Spuls Grant/research support from: Prof. dr. Ph.I. Spuls has done consultancies in the past for Sanofi 111017 and AbbVie 041217 (unpaid), receives departmental independent research grants for TREAT NL registry, for which she is Chief Investigator (CI), from pharma companies since December 2019, is involved in performing clinical trials with many pharmaceutical industries that manufacture drugs used for the treatment of e.g. psoriasis and atopic dermatitis, for which financial compensation is paid to the department/hospital. Harald Vonkeman Speakers bureau: Amgen, BMS, Celgene, Galapagos, GSK, Janssen-Cilag, Lilly, Novartis, Pfizer, Roche, Sanofi-Genzyme, UCB, Grant/research support from: Abbvie, Sanofi-Genzyme, Michael Nurmohamed Speakers bureau: Abbvie, Janssen, Celgene, Grant/research support from: Abbvie, Martijn van Doorn Speakers bureau: Janssen, LEO Pharma, Pfizer, Novartis, Paid instructor for: LEO Pharma, Consultant of: AbbVie, Janssen, LEO Pharma, Pfizer, Celgene, Novartis, TEVA, MSD, Sanofi, AstraZeneca, Grant/research support from: Novartis, Janssen, Bart van den Bemt Speakers bureau: UCB, Pfizer, Sanofi-Aventis, Galapagos, Amgen en Eli Lilly, Naomi Jessurun: None declared